Introduction

At present, if a woman chooses to have an abortion, she almost always has a
surgical procedure. However, a new French medication called RU 486 is now being
used to bring about abortion in very early pregnancy, and scientists are
researching many other therapeutic applications for this revolutionary drug.
Because it stops the gestation of an early pregnancy, RU 486 has
been called an abortion pill.

1. What Is RU 486?

RU 486 (or Mifepristone) is a steroid hormone similar in structure to the
natural hormone progesterone. Invented in 1980 by Dr. Etienne-Emile Baulieu for
the French pharmaceutical company Roussel-Uclaf, RU 486 is the first of a new
generation of birth control drugs called "antiprogestins", considered to be a
breakthrough in birth control technology. (RU 486's name comes from
Roussel-Uclaf's initials plus a serial number.)

2. How Does RU 486 Work?

In a woman's body, the natural hormone known as progesterone is essential for
establishing and maintaining a pregnancy. The name for the hormone, in fact,
comes from the Latin words "pro" (for) and "gestare" (to carry). RU 486 is a
progesterone antagonist (an "antiprogestin").

3. Will RU 486 Completely Replace Surgical Abortion?

No. The RU 486 regime works only during the first 9 weeks of pregnancy, or up
to 63 days from the start of the woman's last menstrual period. After this time,
the woman's own progesterone level is apparently too great to be affected by the
drug.

4. What Is The Background Of RU 486?

Early trials found that RU 486, when taken alone, acted very slowly and had a
significant failure rate. In order to improve its effectiveness, Roussel's
investigators began to combine RU 486 with a follow-up dose of prostaglandin.
(Prostaglandins have been widely used since 1970 to induce uterine
contractions.) The improvement was dramatic; prostaglandins were found to
complement the actions of RU 486.

Over the last fifteen years, dozens of clinical studies on RU 486 have been
conducted with thousands of women in over 20 countries, including France,
Britain, Spain, Germany, the Netherlands, Switzerland, the U.S., Scandinavia,
and the former Soviet Union. To date, RU 486 has been used by over
200,000 women in Europe alone.

5. Where Is RU 486 Being Used Today?

RU 486 in combination with a prostaglandin has been widely used in
France since 1989 for pregnancies up to 7 weeks, and now accounts for
about 30% of all French abortions. In 1991, RU 486 was approved for use in
Britain for pregnancies up to 9 weeks duration. Sweden was the next
country to be licensed to market the drug and testing has now been
completed in the United States. The Chinese are now using RU 486 (in
possible breach of the patent), and their numbers are not included in the
research totals.

RU 486 IS NOT AVAILABLE IN CANADA. Pressure from
the anti-choice movement has succeeded in keeping RU 486 out of Canada for the
forseeable future, despite the support the drug has had from two provincial
governments, the Canadian medical associations, as well as women's groups.

7. Is RU 486 A 'Do-It-Yourself' Abortion Pill?

NO. At the present time, an RU 486/prostaglandin abortion is a three or four
step regimen performed under close medical supervision at specifically
authorized medical centres. Further trials may result in the simplification of
this process, but a certain degree of medical supervision will remain
necessary.

8. How Is RU 486 Administered?

1. A woman must visit an approved clinic for a physical
examination and pregnancy test. Her medical history is screened to
determine if there is any reason why the drug should not be used in her
case. (In those countries with laws which stipulate a waiting period for
abortion, a woman must leave the centre and return after the waiting
period has expired.)

2. At this point she is given RU 486 in tablet form
(usually three pills of 200 mg. each), and swallows them in the presence
of a nurse or doctor before leaving the clinic. (About half of the women
begin to bleed the day after taking RU 486.)

3. A woman must return to the clinic after 48 hours to
receive the prostaglandin which will complete the abortion. (In the future
it may become possible to avoid this separate clinic visit to administer
the prostaglandin.) The woman stays at the clinic for the next 4-6 hours.
Most (up to 90%) abort there; the rest will abort later at home.

4. A woman must return several days later for a
physician's examination to make sure the abortion is complete and to
determine if she has experienced any side effects. Bleeding, similar to a
heavy period, lasts on average for 10-12 days.

9. What Are The Side Effects Of RU 486?

Common side effects include bleeding, menstrual-type pain and cramping, which
are comparable to those of surgical abortion. Women needing painkillers are
given analgesics. Some women also experience some nausea, vomiting or diarrhea
from the prostaglandin.

About one percent of women who take the drug combination experience heavy
bleeding which requires further treatment. In clinical studies on RU 486,
incomplete abortion occurred in 2-3% of cases and pregnancy persisted in 1%.
These women then required surgical abortions.

10. How Effective Is RU 486?

RU 486, in conjunction with a prostaglandin, is 95.5% effective
in inducing abortion during the first 7 weeks of pregnancy. It has
close to the same level of effectiveness as surgical abortion performed during
the early weeks.

11. How Safe Is RU 486?

Studies have shown RU 486/prostaglandin abortions to be safe,
with a low number of complications.

Of course, RU 486 cannot be used by all women. Those who have been receiving
long-term corticosteroid therapy, who have a blood clotting disorder, chronic
adrenal gland failure, an ectopic pregnancy, or any contraindication to
prostaglandins are not able to use this method of abortion.

A few years ago, three cases of major cardiovascular complications were
reported, all attributable to the use of one prostaglandin (sulprostone) with RU
486. Two of these women (both over 35 and heavy smokers) experienced cardiac
problems and the third (a heavy smoker with 12 previous pregnancies) died of a
heart attack after receiving the sulprostone. Sulprostone is no longer being
used with RU 486; the more gentle-acting Misoprostal is now the prostaglandin of
choice.

Taking into account the numbers of women who have used the regimen, the rate
of adverse occurrences is low compared to other drugs or medical procedures. A
single death out of the more than 200,000 administrations given to date of RU
486 with a prostaglandin (1: 200,000) compares favourably to the death rates
associated with vacuum aspiration abortion (1: 200,000), child birth (1: 14,300)
and illegal abortion (1: 3,000).

12. What About Long-Term Health Risks?

Extensive clinical tests since 1982 have not revealed any
evidence of long-term health effects on women who use RU 486, and
such effects appear unlikely given the very short time women are exposed to the
drug. One of the reasons doctors like RU 486 is that it metabolizes quickly and
is soon out of the system; studies show that half the dose has left the body 20
hours after being taken. Although there is no indication that RU 486 causes
birth defects or genetic damage when it fails to terminate a pregnancy,
follow-up surgical abortions are always recommended in such cases.

13. What Are The Disadvantages Of RU 486?

RU 486 is only effective during the earliest weeks of pregnancy, a time
when many women do not yet know they are pregnant.

RU 486 takes longer than a surgical abortion. A vacuum aspiration abortion
is done in 15 minutes, whereas RU 486 takes two days or more and, at present,
requires two trips to the clinic for the abortion itself.

As a relatively new procedure, the long-term safety of RU 486 cannot yet
be confirmed.

14. What Are The Advantages Of RU 486?

RU 486 can be administered to a woman as soon as she knows that she is
pregnant and wants to have an abortion. By contrast, a woman must wait until
the 6th-8th week before she is able to have a vacuum aspiration abortion.

Pregnancy termination with RU 486 is non-surgical, requires no anesthesia
and puts women at no risk of perforation, damage to the cervix or infection
from instruments.

Many women prefer RU 486 because it allows them greater psychological
control over the termination of pregnancy. It is also considered less
physically invasive and appears more similar to a miscarriage than to an
induced abortion.

RU 486 can make abortion a more private experience. Women are usually
alone when they abort. Further research may lead to a protocol in which only a
woman and her own doctor are involved in the administration of RU 486.

RU 486 has the potential to make abortion more accessible. Administering
it does not require the same level of specialized medical expertise or time as
surgical abortion. Furthermore, RU 486 should eventually be cheaper than a
surgical abortion.

RU 486 has tremendous potential for use in developing countries where
hundreds of thousands of women each year are injured or die from unsafe
abortions.

15. What Other Uses Does RU 486 Have?

The medical community has identified RU 486 as a promising
treatment for several major medical problems, including:

16. How Has The Medical Science Community Reacted To RU 486?

The international medical science community has formally recognized the
importance of RU 486 and supported its testing. Dr. Etienne-Emile Baulieu won
the coveted Lasker Prize in 1989 for discovering RU 486. RU486, the "abortion
pill", is currently not available to women in Canada, except those participating
in clinical trials being conducted in Montreal, Sherbrooke, Vancouver and
Toronto.

"The development of mifepristone (RU 486) is an

advance in reproductive medicine of

the same magnitude as the development

of the hormonal contraceptive pill . . ."

Sir Malcolm Macnaughton, - former President, Royal College of Obstetricians and Gynaecologists, U.K.

Dr. Etienne-Emile Baulieu, inventor of RU
486

17. How Have Anti-Abortion Groups Reacted to RU 486?

The anti-choice lobby has reacted strongly against RU 486, and has been
effective in curtailing its availability, even for medical research into the
drug's other applications. In October 1988, after some company employees had
received death threats, Roussel abruptly withdrew the new drug from the market
in France, although the French government promptly forced its return. The
anti-choice lobby was temporarily successful in the U.S., where a Food and Drug
Administration order banned the import of RU 486 from 1989 until 1993. Opponents
of abortion have organized boycotts against Roussel-Uclaf, its German parent
company, Hoechst A.G., as well as their American affiliates, and have threatened
to boycott any other pharmaceutical company which would make RU 486
available.

"RU 486 [has become] the

moral property of women,

not just the property of the

drug company."

France's Health Minister Claude Evin, in 1988.

18. How Has The Women's Movement Reacted To RU 486?

Feminist groups strongly support the testing of RU 486 as a promising
development in the much-threatened area of women's reproductive
choice. They see RU 486 as a significant medical breakthrough which
has the potential to improve the health of women around the
world.

A few feminists have criticized RU 486 as a cumbersome and risky medication.
According to feminist supporters of RU 486, these criticisms seem to be premised
on a more general, ideological opposition to all hormone-related drugs and new
reproductive technologies. While acknowledging that RU 486 is not perfect, its
supporters contend that it offers a means of early abortion without surgery
which is safe, effective, and acceptable to women.

19. Clinical Trials of RU 486.

In September 2000, "Mifepristone", also known as "RU486" or the "abortion pill" became available in the United States. It is being provided at 60 clinics across the United States. This pill is not available over the Internet or by mail order. This means that if you live in a country where RU486 is not legal or not available, you cannot order it from the United States and use it at home. If you live in the United States and would like to know where you can find Mifepristone near you, call the National Abortion Federation toll-free at 1-800-772-9100. This line operates Monday to Friday only. The cost is about $450. For further information about Mifepristone in the American context, see the web site www.earlyoptions.org.If you live in Canada, the abortion pill is not widely available. Clinical trials are occurring in four cities: Vancouver, Toronto, Montreal and Sherbrooke. To find out where you can obtain the drug in these cities, call one of the abortion clinics listed in your local yellow pages.